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Merck (MSD) announced today that the US FDA has accelerated the approval of its anti-PD-1 therapy Keytruda in combination with trastuzumab and fluoropyrimidine and platinum-based chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2 Patients with positive gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma.
Stomach cancer is the fifth most common cancer in the world and the third leading cause of cancer death.
Keytruda is a blockbuster anti-PD-1 therapy developed by Merck.
This accelerated approval is supported by the ongoing randomized, double-blind, placebo-controlled clinical trial KEYNOTE-811.
In terms of safety, 6% of the patients in the Keytruda combination therapy group and the control group discontinued their participation in the trial due to adverse reactions.
In the Keytruda group and the placebo group, diarrhea (53% vs.
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